(115 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard insulin syringe, with no mention of AI or ML.
No
Explanation: A therapeutic device implies that the device itself delivers therapy or treatment. This device is an insulin syringe, which is used to administer insulin (the therapy), but the syringe itself is a delivery mechanism, not a therapeutic device.
No
The device is described as an insulin syringe for subcutaneous injection of insulin, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical medical device (syringe) with hardware components (barrel, needle, plunger, gasket, cap). There is no mention of software as the primary or sole component.
Based on the provided information, the Top Fine® disposable sterile insulin syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for subcutaneous injection of insulin." This describes a device used to administer a substance into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a syringe designed for injecting medication. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Top Fine® disposable sterile insulin syringe is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the subcutaneous injection of insulin.
The Top Fine® disposable sterile insulin syringes are intended for subcutaneous injection of insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. Rx only. The devices operate on the principles of common piston syringes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Both bench and clinical tests were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. Clinical testing was performed to determine adequacy of instructions for use, the range of patient population, performance characteristics, and reliability. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
K063348 page 1 of 1
MAR 0 ] 2007
510(K) Summary Daejin Tech Medical Manufacturing Co., Ltd. 536-70 Kumkwang-Ri KumKwang-Myun, Ansung-Si, Kyunggi-Do, Korea Contact person: Simon Bang, President Tel : 82-31-671-2161 Fax : 82-31-671-2162 Date prepared: October 25, 2006
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- Trade Name: Top Fine® Insulin Syringe Common Name: Insulin syringe Classification Name: Syringe, piston, product code FMF, Regulation: 880.5860 Class of device: Class II.
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- The legally marketed device to which we are claiming equivalence [807.92(a)(3)| : BD Insulin Syringe K024112.
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- Description of device: Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. Rx only. The devices operate on the principles of common piston syringes.
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- Intended use: For the subcutaneous injection of insulin.
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- Technological characteristics: The Top Fine® Insulin Syringes and the predicate devices have identical technological characteristics and perform the same way as common piston syringes. Whereas the predicate syringes are gamma sterilized, these syringes are EO sterilized.
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- Performance: Both bench and clinical tests were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. Clinical testing was performed to determine adequacy of instructions for use, the range of patient population, performance characteristics, and reliability. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
1
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MAR 0 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Daejin Tech Medical Manufacturing Company Limited C/O Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K063348
Trade/Device Name: Top Fine® Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 20, 2007 Received: February 23, 2007
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Kamm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Suser Runne
$\theta$
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:_ Top Fine® Insulin Syringe
Indications For Use:
The Top Fine® disposable sterile insulin syringes are intended for subcutaneous injection of insulin.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C
Page 1 of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number. K96374